Summary
This SOP establishes a policy for the submission and review of protocols that utilize the BIAC scanners.
Scope
These policies apply to all Duke and UNC investigators who wish to conduct scientific studies that utilize the BIAC MRI scanners.
Definitions
- Subject - An individual who is participating in an experimental protocol at BIAC and has not taken the BIAC safety course.
- Experimenter - The investigator, research assistant, or MRI operator who is responsible for the subject and conducting the experiment.
Policies and Procedures
Overview:
Because of heavy user demand, experimental time on BIAC's MRI systems is limited. A scientific review committee composed of BIAC faculty and affiliated investigators will therefore review research proposals and award magnet time on a priority basis. All investigators, including core BIAC faculty and post-doctoral fellows, must submit research proposals to obtain access to the scanners.
New PIs are encouraged to discuss their planned use of the scanners with the BIAC Director prior to submitting a protocol for scientific review. As noted below, PIs must discuss their planned use of BIAC facilities before submitting grants that depend upon their access to these facilities. PIs should note that BIAC is under no obligation to provide scanner time to funded projects that have not been submitted for scientific review.
Eligibility:
Investigators at Duke University and the University of North Carolina at Chapel Hill may apply for scanner time to conduct experimental studies at the BIAC.
Review Criteria:
The review criteria include scientific merit and significance, technical feasibility, relevance to the BIAC mission, and funding status.
Funding:
The BIAC receives no annual operating stipend, and thus must recover all of its operating expenses from grants and hourly scan charges. Please contact the BIAC front office for the current charge rate for all NIH, NIMH, CDC, and NSF grants. This charge includes technician time, but it does not include data analysis, filming, clinical diagnostic film review, training costs, or sedation. The BIAC reserves the right to modify the hourly scan rate based upon changes in usage patterns.
Federal regulations require that no other non-federal agency, company, or group can receive a lower scan charge than that specified in federal grants. However, BIAC typically charges a higher hourly scan rate for industry-sponsored grants and contracts. PIs contemplating the submission of a non-federally funded grant or contract, such as that submitted to a pharmaceutical company, must discuss scan charges with the BIAC Director in advance of submission.
Because imaging hours are finite, all PIs must discuss their intended use of BIAC scanners with the BIAC Director prior to grant submission.
IRB or IACUC Approval:
A protocol may be submitted to BIAC for scientific review while IRB or IACUC approval is still pending. However, an investigator will not be able to schedule time on the web-based scanner schedule until BIAC has received proof of IRB or IACUC final approval. The time-stamped approval form should be emailed to research@biac.duke.edu .
The scheduling program checks a database for IRB and IACUC expiration dates and automatically disables further scheduling unless a renewal approval has been received at the BIAC office.
UNC PIs should note that IRB or IACUC approval will be required from both Duke and UNC prior to scheduling.
Frequency of meetings for the BIAC Scientific Review Committee:
The Scientific Review Committee generally meets on the first Monday of the month. Proposals submitted throughout the month will be reviewed at the next scheduled committee meeting.
Expedited reviews:
Under extraordinary circumstances, the Chairman of the Scientific Review Committee can expedite a review to permit the expeditious acquisition of data. For example, this might occur for a protocol that depends upon recruiting rare patient types, or when pilot data is required to support a letter of intent or RFA with a short deadline. A protocol that lacks IRB or IACUC approval can never be expedited.
Review feedback:
A letter summarizing the review will be sent to the PI via email. Protocols may be approved, approved with minor modifications, deferred for additional information, or disapproved. In some instances, the Scientific Review Committee may invite the PI to the review session for clarification of the protocol.
PIs who attend the review meeting to help clarify their projects for the committee must leave the room prior to the vote. This rule also applies to PIs who are committee members.
Appeals:
PIs who believe that their protocols did not receive a fair review can appeal to the BIAC Director, or to the BIAC Administrative Oversight Committee.
Format of application (2-3 pages maximum):
All BIAC Study Proposals will be submitted using the REDCap survey (see Getting Started for more information).
Please be sure to have the following information or documents ready before accessing the survey:
Information:
- Title of Proposal
- Suggested Experiment ID (e.g. Memory.01)
- Principal Investigator and Department
- Faculty Sponsor
- Responsible Investigator
- Other Investigator(s)
- Contact Information
- Experimenter(s)
- Scheduler(s)
- Person(s) with data access
- Data Analysis
- Scanner Required
- Funding Source
- IRB Registry number and approval date
- Length and Number of requested imaging Slots
- MRI Technologist Required (Yes or No)
- BIAC disk needed (Yes or No)
- Other special requirements (e.g. scheduling, special equipment, etc.)
- If animal study, method for disinfecting scanner after use
Documents:
- Study Description (Short Synopsis of Study)
- Rationale and Scientific Significance
- Experimental Design
- Imaging Protocol
- Data Analysis
- IRB confirmation letter
- IRB approved consent(s)
Following approval:
Once a protocol is approved, a PI will be provided with a protocol name (e.g., Memory.01). This name will appear on the protocol list when the PI accesses the BIAC Web calendar and must be used to schedule all Subjects under this approved protocol. Scheduling can commence once this protocol name has been assigned and an IRB or IACUC final approval form has been received.
PIs who require a BIAC computer account, an electronic key to the BIAC facilities, or who have problems in accessing the BIAC calendar should contact the BIAC Help Desk.
PIs should note that safety training is required for all individuals from the PI's group who require entry into the MRI suite. Please refer to Research Safety for instructions.
Renewals:
Approval is for a one-year period. Before your study is set to expire, you will receive an email on how to renew your study. This email will contain a unique REDCap survey link, please do not share this link or use it for other studies.
The format of the renewal application is similar to the initial submission, except that the Description section should focus on describing the previous year's scanner usage and results, and any changes in the experiment proposed for the upcoming year.